IH Transfer Impression Coping AIHTIMH4014

GUDID 08800041352807

SEWON MEDIX IH Transfer Impression Coping Mini Hex Set Product, Ø4.0x14.6mm

sewon medix Inc.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800041352807
• NIH Device Record Key: 86a368bf-cc14-462e-b03f-41b8df579f4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH Transfer Impression Coping
• Version Model Number: AIHTIMH4014
• Catalog Number: AIHTIMH4014
• Company DUNS: 688731065
• Company Name: sewon medix Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com
• Phone: +1-224-531-3099
• Email: hsong@mydental.com

Device Dimensions

• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter
• Stent Diameter: 4.8 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800041352807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153521

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-21
• Device Publish Date: 2020-12-11

On-Brand Devices [IH Transfer Impression Coping]

• 08800041352807: SEWON MEDIX IH Transfer Impression Coping Mini Hex Set Product, Ø4.0x14.6mm
• 08800041352791: SEWON MEDIX IH Transfer Impression Coping Mini Hex Set Product, Ø4.0x11.6mm